Glaukos has completed patient enrolment in its Phase II clinical trial evaluating GLK-321 for the treatment of Demodex blepharitis, using its iLution platform designed for dropless, transdermal drug delivery.
The double-masked, dose-ranging, multi-centre, placebo-controlled, parallel-group, randomised trial will assess the tolerability, efficacy, and safety in patients affected by this eyelid condition.
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A total of 275 patients have been randomised at clinical sites across the US. The primary efficacy endpoint is the proportion of study eyes achieving elimination of collarettes after six weeks of treatment with GLK-321 at three different dose levels.
Delivered through Glaukos’ iLution platform, the therapy uses a cream-based pharmaceutical formulation applied to the eyelids. Its active compound is physostigmine.
The iLution system aims to improve patient compliance and reduce side effects often linked with traditional eye drop therapies.
Glaukos chairman and CEO Thomas Burns said: “Completion of enrolment in this Phase II study marks an important milestone in the advancement of our iLution pharmaceutical platform and broader ocular surface disease pipeline.
“Demodex blepharitis represents a large, growing, and significantly underpenetrated market opportunity, with potentially millions of patients who remain undiagnosed or untreated today.
“As awareness and diagnosis of this chronic condition continue to increase, we believe there is a substantial need for differentiated therapeutic approaches that expand treatment options and improve patient access to care.”
Demodex blepharitis is a chronic eyelid disease associated with Demodex mite infestation.
Symptoms include eyelid inflammation, irritation, redness, itching, and collarettes at the base of the eyelashes. It is often underdiagnosed and impacts ocular surface health and patient quality of life.
In October 2024, Glaukos announced plans to file for US approval of its iLink corneal cross-linking therapy Epioxa (Epi-on) for treating keratoconus after the therapy met the primary endpoint in a Phase III trial.
